Trial Outcomes & Findings for A Study of LY2484595 on Pharmacokinetics in Healthy Participants (NCT NCT01448824)
NCT ID: NCT01448824
Last Updated: 2019-04-02
Results Overview
The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
82 participants
Primary outcome timeframe
Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)
Results posted on
2019-04-02
Participant Flow
This was a 2-part study, multiple ascending dose (MAD) and drug drug interaction (DDI). Participants were randomized to (Part 1) to 4 cohorts (Cohorts A through D) and randomized to receive either LY2484595 (5 ascending dose levels) or placebo. Cohort A consisted of 2 periods separated by a washout period of 14 days. DDI had 2 periods.
Participant milestones
| Measure |
Part 1 Cohort A Sequence 1
Period 1:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.
Washout period lasting ≥14 days.
Period 2:
LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.
|
Part 1 Cohort A Sequence 2
Period 1:
Placebo: dose-matched tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.
Washout period lasting ≥ 14 days
Period 2:
LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.
|
Part 1 Cohort A Sequence 3
Period 1:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
Washout period lasting ≥14 days
Period 2:
Placebo: tablets, oral administration, QD on Days 1 through 14 of Period 2
|
Part 1 (Cohorts B Through D): Placebo
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort B
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort C
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort D
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 2 Cohort E
Period 1:
LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1.
Washout period lasting ≥ 14 days
Period 2:
Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.
LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 Period 1: Multiple Ascending Dose
STARTED
|
12
|
4
|
4
|
10
|
16
|
12
|
12
|
0
|
|
Part 1 Period 1: Multiple Ascending Dose
Received at Least 1 Dose of Study Drug
|
12
|
4
|
4
|
10
|
16
|
12
|
12
|
0
|
|
Part 1 Period 1: Multiple Ascending Dose
COMPLETED
|
12
|
4
|
4
|
9
|
14
|
10
|
11
|
0
|
|
Part 1 Period 1: Multiple Ascending Dose
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
2
|
1
|
0
|
|
Part 1: Washout Period
STARTED
|
12
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Washout Period
COMPLETED
|
11
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1: Washout Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 Period 2: Multiple Ascending Dose
STARTED
|
11
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 Period 2: Multiple Ascending Dose
Received at Least 1 Dose
|
11
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 Period 2: Multiple Ascending Dose
COMPLETED
|
11
|
4
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 Period 2: Multiple Ascending Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 Period 1: Drug-drug Interaction
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
|
Part 2 Period 1: Drug-drug Interaction
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
|
Part 2 Period 1: Drug-drug Interaction
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2 Period 1: Drug-drug Interaction
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2: Washout Period
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2: Washout Period
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2: Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 Period 2: Drug-drug Interaction
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2 Period 2: Drug-drug Interaction
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
|
Part 2 Period 2: Drug-drug Interaction
Completed Dosing on Day 5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
|
Part 2 Period 2: Drug-drug Interaction
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
8
|
|
Part 2 Period 2: Drug-drug Interaction
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part 1 Cohort A Sequence 1
Period 1:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.
Washout period lasting ≥14 days.
Period 2:
LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.
|
Part 1 Cohort A Sequence 2
Period 1:
Placebo: dose-matched tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1.
Washout period lasting ≥ 14 days
Period 2:
LY2484595: 1800 mg, tablets, oral administration, QD on Days 1 through 14 of Period 2.
|
Part 1 Cohort A Sequence 3
Period 1:
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
Washout period lasting ≥14 days
Period 2:
Placebo: tablets, oral administration, QD on Days 1 through 14 of Period 2
|
Part 1 (Cohorts B Through D): Placebo
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort B
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort C
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 Cohort D
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 2 Cohort E
Period 1:
LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1.
Washout period lasting ≥ 14 days
Period 2:
Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2.
LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1 Period 1: Multiple Ascending Dose
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part 1 Period 1: Multiple Ascending Dose
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
|
Part 1 Period 1: Multiple Ascending Dose
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part 1: Washout Period
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 Period 1: Drug-drug Interaction
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 2: Drug-drug Interaction
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 2: Drug-drug Interaction
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 2 Period 2: Drug-drug Interaction
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2484595 on Pharmacokinetics in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 (Cohort A) Sequence 1
n=12 Participants
Participants received 100 milligrams (mg) LY2484595 (tablets, oral administration) QD on Days 1 through 14. Then, received 1800 mg LY2484595 QD on Days 1 through 14 period 2.
|
Part 1 (Cohort A) Sequence 2
n=4 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 and 1800 mg LY2484595 on Days 1 through 14 of Period 2).
|
Part 1 (Cohort A) Sequence 3
n=4 Participants
Participants received 100 mg LY2484595 (tablets, oral administration) once daily (QD) on Days 1 through 14. Then, received placebo QD on Days 1 through 14 period 2.
|
Part 1 (Cohort B Through D) Placebo
n=10 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14.
|
Part 1 (Cohort B)
n=16 Participants
Participants received 300 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
|
Part 1 (Cohort C)
n=12 Participants
Participants received 600 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
|
Part 1 (Cohort D)
n=12 Participants
Participants received 1200 mg LY2484595 (tablets, oral administration) QD on Days 1 through 14.
|
Part 2 (Cohort E)
n=12 Participants
Participants received 100 mg LY2484595 (tablet, oral administration) as a single dose on Day 1 of Period 1. After a washout period lasting ≥14 days, participants received 400 mg ketoconazole (tablet, oral administration, QD) on Days 1 through 4 of Period 2, 400 mg ketoconazole (tablet, oral administration) and 100 mg LY2484595 (tablet, oral administration) on Day 5 of Period 2, and 400 mg ketoconazole (tablet, oral administration, QD) on Days 6 through 14 of Period 2.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
41.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
39.4 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
41.1 years
STANDARD_DEVIATION 14.3 • n=21 Participants
|
39.1 years
STANDARD_DEVIATION 10.7 • n=8 Participants
|
45.8 years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
36.6 years
STANDARD_DEVIATION 7.9 • n=24 Participants
|
39.8 years
STANDARD_DEVIATION 11.5 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
63 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
41 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
53 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
82 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Part 1: Baseline through ≥14 days after last dose of study drug (≥Day 28)Population: All participants who received at least 1 dose of study drug.
The number of participants with 1 or more AEs is summarized cumulatively. In addition, the number of participants with any serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=18 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=16 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=12 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=12 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
n=15 Participants
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
AEs
|
7 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
11 Participants
|
|
Part 1: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post DosePopulation: Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
The geometric least squares (LS) means for the maximum observed plasma concentration (Cmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=12 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=10 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
|
331.83 Nanograms per milliliter (ng/mL)
Interval 236.06 to 466.45
|
643.99 Nanograms per milliliter (ng/mL)
Interval 448.78 to 924.12
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post DosePopulation: Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
The median times to maximum observed plasma concentration (Tmax) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=10 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=10 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
|
3.00 Hours (h)
Interval 2.0 to 4.0
|
3.00 Hours (h)
Interval 2.0 to 3.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part 2, Period 1, Day 1 through Day 8: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post Dose; Period 2, Day 5 through Day 15: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240 Hours Post DosePopulation: Participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
The geometric least squares (LS) means of area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of LY2484595 following administration of LY2484595 alone and with ketoconazole are reported. Least squares means were calculated from an analysis of variance (ANOVA) model with a fixed effect for treatment and a random effect for participant. The LS means for each treatment and the 90% confidence intervals (CI) for the difference in means were back transformed from the log scale to provide estimates of the geometric means and 90% CIs for the ratio of the geometric means (LY2484595 coadministered with ketoconazole and LY2484595 alone).
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=12 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=9 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
|
5265 Nanograms * hours per milliliter
Interval 4106.0 to 6751.0
|
12471 Nanograms * hours per milliliter
Interval 9422.0 to 16508.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 21Population: Participants who received at least 1 dose of LY2484595 or placebo and had evaluable pharmacodynamic (CETP) data.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=18 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=15 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=11 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=11 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
n=15 Participants
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline to Day 21 in Cholesteryl Ester Transfer Protein (CETP) Activity
|
1.3 Picomoles per milliliters per minute
Standard Deviation 6.9
|
-0.4 Picomoles per milliliters per minute
Standard Deviation 3.1
|
-0.4 Picomoles per milliliters per minute
Standard Deviation 6.3
|
-9.1 Picomoles per milliliters per minute
Standard Deviation 8.8
|
-9.5 Picomoles per milliliters per minute
Standard Deviation 5.0
|
-12.9 Picomoles per milliliters per minute
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) and Day 21Population: Participants who received at least 1 dose of LY2484595 or placebo during Period 1 and had evaluable pharmacodynamic (HDL-C, LDL-C, TG) data.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=14 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=15 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=11 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=11 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
HDL-C
|
-0.08 Millimoles per liter (mmol/L)
Standard Deviation 0.17
|
0.35 Millimoles per liter (mmol/L)
Standard Deviation 0.22
|
0.49 Millimoles per liter (mmol/L)
Standard Deviation 0.31
|
0.77 Millimoles per liter (mmol/L)
Standard Deviation 0.49
|
0.80 Millimoles per liter (mmol/L)
Standard Deviation 0.22
|
—
|
|
Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
LDL-C
|
-0.42 Millimoles per liter (mmol/L)
Standard Deviation 0.74
|
-0.16 Millimoles per liter (mmol/L)
Standard Deviation 0.31
|
-0.48 Millimoles per liter (mmol/L)
Standard Deviation 0.55
|
-1.15 Millimoles per liter (mmol/L)
Standard Deviation 0.93
|
-1.01 Millimoles per liter (mmol/L)
Standard Deviation 0.57
|
—
|
|
Pharmacodynamics: Change From Baseline to Day 21 in High-density Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
TG
|
0.56 Millimoles per liter (mmol/L)
Standard Deviation 0.87
|
0.55 Millimoles per liter (mmol/L)
Standard Deviation 0.81
|
0.44 Millimoles per liter (mmol/L)
Standard Deviation 0.61
|
0.26 Millimoles per liter (mmol/L)
Standard Deviation 0.38
|
0.52 Millimoles per liter (mmol/L)
Standard Deviation 0.57
|
—
|
SECONDARY outcome
Timeframe: Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post DosePopulation: Participants who received at least 1 dose of LY2484595 and had evaluable LY2484595 concentration data.
The maximum observed plasma concentrations (Cmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=16 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=12 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=12 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=15 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Day 1
|
628 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79
|
1990 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
2720 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 59
|
4450 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 53
|
3580 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
—
|
|
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of LY2484595
Day 14
|
978 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 41
|
1970 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
4180 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
5410 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
5750 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
—
|
SECONDARY outcome
Timeframe: Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post DosePopulation: Participants who received at least 1 dose of study drug and had evaluable LY2484595 concentration data.
The times of maximum observed plasma concentrations (tmax) of LY2484595 after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=16 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=12 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=12 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=15 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Day 1
|
3.00 Hours (h)
Interval 2.0 to 8.0
|
3.00 Hours (h)
Interval 1.0 to 8.0
|
3.00 Hours (h)
Interval 2.0 to 4.0
|
2.00 Hours (h)
Interval 1.0 to 8.0
|
2.00 Hours (h)
Interval 1.0 to 4.0
|
—
|
|
Pharmacokinetics: Time of Maximum Observed Plasma Concentration (Tmax) of LY2484595
Day 14
|
4.00 Hours (h)
Interval 2.0 to 6.0
|
2.00 Hours (h)
Interval 2.0 to 4.0
|
2.50 Hours (h)
Interval 1.0 to 4.0
|
2.00 Hours (h)
Interval 1.0 to 6.0
|
3.00 Hours (h)
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: Part 1, Periods 1 and 2, Day 1: Predose, 1, 2, 3, 4, 6, 8, 12, and 24 Hours Postdose; Day 14 through Day 21: Predose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 Hours Post DosePopulation: All participants who received at least 1 dose of LY2484595 and had at least 3 consecutive plasma LY2484595 concentrations above the lower limit of quantification with at least 1 of these concentrations following the maximum observed plasma concentration (Cmax).
Exposure to LY2484595 in terms of the area under the concentration-time curves (AUC) after a single dose and after once daily (QD) dosing for 14 consecutive days are reported.
Outcome measures
| Measure |
Part 1 (Cohorts A Through D): Placebo
n=16 Participants
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A): 100 mg LY2484595
n=16 Participants
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1 (Cohort B): 300 mg LY2484595
n=12 Participants
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=12 Participants
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=15 Participants
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1, Period 2 (Cohort A): 1800 mg LY2484595
LY2484595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Day 1
|
4780 Nanograms * hour per milliliter
Geometric Coefficient of Variation 57
|
14500 Nanograms * hour per milliliter
Geometric Coefficient of Variation 47
|
21300 Nanograms * hour per milliliter
Geometric Coefficient of Variation 55
|
36300 Nanograms * hour per milliliter
Geometric Coefficient of Variation 46
|
31300 Nanograms * hour per milliliter
Geometric Coefficient of Variation 63
|
—
|
|
Pharmacokinetics: Area Under the Concentration-time Curve (AUC) of LY2484595
Day 14
|
8110 Nanograms * hour per milliliter
Geometric Coefficient of Variation 30
|
17900 Nanograms * hour per milliliter
Geometric Coefficient of Variation 27
|
36200 Nanograms * hour per milliliter
Geometric Coefficient of Variation 38
|
46900 Nanograms * hour per milliliter
Geometric Coefficient of Variation 43
|
56600 Nanograms * hour per milliliter
Geometric Coefficient of Variation 30
|
—
|
Adverse Events
Part 1 (Cohorts A Through D)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1, Period 1 (Cohort A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1, Period 2 (Cohort A)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Part 1 (Cohort B): 300 mg LY2484595
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 (Cohort C): 600 mg LY2484595
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (Cohort D): 1200 mg LY2484595
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2, Period 1: 100 mg LY2484595
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2, Period 2: 400 mg Ketoconazole
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 (Cohorts A Through D)
n=18 participants at risk
Placebo: tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1 (all cohorts) and Days 1 through 14 of Period 2 (Cohort A only)
|
Part 1, Period 1 (Cohort A)
n=16 participants at risk
LY2484595: 100 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 1
|
Part 1, Period 2 (Cohort A)
n=15 participants at risk
LY284595: 1800 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14 of Period 2
|
Part 1 (Cohort B): 300 mg LY2484595
n=16 participants at risk
LY2484595: 300 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort C): 600 mg LY2484595
n=12 participants at risk
LY2484595: 600 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 1 (Cohort D): 1200 mg LY2484595
n=12 participants at risk
LY2484595: 1200 milligrams (mg), tablets, oral administration, once daily (QD) on Days 1 through 14
|
Part 2, Period 1: 100 mg LY2484595
n=12 participants at risk
Period 1:
LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1
Washout period lasting ≥ 14 days
Period 2:
Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2
LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
|
Part 2, Period 2: 400 mg Ketoconazole
n=11 participants at risk
Period 1:
LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1
Washout period lasting ≥ 14 days
Period 2:
Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2
LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
|
Part 2, Period 2: 100 mg LY2484595 + 400 mg Ketoconazole
n=10 participants at risk
Period 1:
LY2484595: 100 milligrams (mg), tablet, oral administration, single dose on Day 1 of Period 1
Washout period lasting ≥ 14 days
Period 2:
Ketoconazole: 400 mg, tablet, oral administration, once daily (QD) on Days 1 through 14 of Period 2
LY2484595: 100 mg, tablet, oral administration, single dose on Day 5 of Period 2
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
40.0%
6/15 • Number of events 9
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
27.3%
3/11 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral mucosal erythema
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye irritation
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
40.0%
6/15 • Number of events 7
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
66.7%
10/15 • Number of events 13
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 3
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling jittery
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Irritability
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
16.7%
2/12 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
26.7%
4/15 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
40.0%
6/15 • Number of events 16
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
25.0%
3/12 • Number of events 4
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
36.4%
4/11 • Number of events 5
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
6.7%
1/15 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.6%
1/18 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
9.1%
1/11 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
10.0%
1/10 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
8.3%
1/12 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Capillary fragility
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/15
All randomized participants who received at least 1 dose of study drug.
|
6.2%
1/16 • Number of events 1
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/18
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
13.3%
2/15 • Number of events 2
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/16
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/12
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/11
All randomized participants who received at least 1 dose of study drug.
|
0.00%
0/10
All randomized participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60